GPvP Committee
03/06/2015 15:56
When moving to a paperless system for management of ICSR processing there are a number of considerations that need addressing in addition to the standard expectations for validation, audit trail, back up functionality, data space, access management in the short and long terms and system speed etc. These would include a robust process for QC of the content of the documents e.g. has there be a corruption of the email or attachments during the upload process, clear naming conventions (such as whether the email contains source data, initial or follow up information, queries) and whether there is the functionality for read access to the information filed in Argus. Another item for Argus is data protection and whether personal identifiers need to be redacted prior to uploading the data, i.e. you may need to maintain the original at the country site too.
Something else to consider would be whether it was possible to open any attachments associated with an email or whether these attachments would be individually PDF’d (in which case ensuring clarity as to which attachment belonged to which email would be essential to maintain oversight of the audit trail/timelines for these documents). Multiple personnel having Data Edit access to Argus can pose the risk of potential deletion of emails or supporting attachments in error and if emails were deleted how this would be identified. In using Argus there are also action items which either the affiliate or central group can use to document items for completion and the audit trail says if they were deleted or not.
The business process associated with the database needs to be clearly documented as to what correspondence would need to be kept.
